Abstract
Management of apathy, depression and anxiety in Parkinson’s disease (PD) represents a challenge. Dopamine agonists have been suggested to be effective. This multicenter, randomized (1:1), double-blind study assessed the 6-month effect of rotigotine versus placebo on apathy, depression and anxiety in de novo PD. The primary outcome was the change of apathy, measured with the LARS. The secondary outcomes were the change in depression and anxiety, measured with BDI-2 and STAI-trait and state. Forty-eight drug-naive PD patients were included. The primary outcome was not reached, with a surprisingly high placebo effect on apathy (60%). There was no significant difference in the change of depression at 6 months between rotigotine and placebo. Trait-anxiety was significantly improved by rotigotine compared to placebo (p = 0.04). Compared to placebo, low dose rotigotine significantly improved trait anxiety, but not apathy and depression. The major placebo effect on apathy points towards the importance of a multidisciplinary and tight follow-up in the management of neuropsychiatric symptoms.
Highlights
Neuropsychiatric symptoms are common and disabling in Parkinson’s disease (PD)[1,2].Apathy, a disorder characterized by lack of motivation and goaldirected behaviors, affects almost 40% of PD patients in isolation, or with depression and anxiety[2,3,4]
There are no randomized-controlled studies designed to assess the efficacy of a dopamine agonist on apathy and hypodopaminergic behaviors in de novo PD. The aim of this randomized-controlled study was to assess the effect of rotigotine, a 24-h continuous transdermal non-ergot dopamine agonist[21] on apathy, depression and anxiety in de novo PD
The mean dose reached at the end of the titration phase in the placebo group was 8 ± 0 mg/day, and in the rotigotine group 7 ± 1.8 mg/day
Summary
A disorder characterized by lack of motivation and goaldirected behaviors, affects almost 40% of PD patients in isolation, or with depression and anxiety[2,3,4]. The dopaminergic medication has been shown to improve motivation and apathy in PD patients[8,9,10,11,12,13,14]. Depression and anxiety have been conceptualized as hypodopaminergic symptoms related to PD, and opposed to hyperdopaminergic behaviors, including impulse control disorders, related to dopaminergic treatment[20]. There are no randomized-controlled studies designed to assess the efficacy of a dopamine agonist on apathy and hypodopaminergic behaviors in de novo PD. The aim of this randomized-controlled study was to assess the effect of rotigotine, a 24-h continuous transdermal non-ergot dopamine agonist[21] on apathy, depression and anxiety in de novo PD
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